mp.weixin.qq.com·· 3 hours agoPickScore82
Trastuzumab Deruxtecan Receives Conditional Tumor-Agnostic HER2 Approval in China
In brief
Trastuzumab deruxtecan (Enhertu) has received conditional approval in China as monotherapy for adults with unresectable or metastatic solid tumors expressing HER2 at IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval is based on four phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03, with full approval contingent on clinical benefit demonstrated in confirmatory trials.
Why it matters
Four phase II trials supply ORR, PFS, OS and safety data across tumor types and identify the confirmatory trials underpinning conditional approval.
Source: mp.weixin.qq.com · mp.weixin.qq.com